Leader Nighttime Cold and Flu

Product NDC
70000-0184
11-digit product format
700000184
Labeler code
70000
Product ID
70000-0184_f7ee3a55-40f2-4ce7-9dba-cb0355d73dea
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-11-15
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECardinal Health 110, LLC. dba Leader9b1a5dbe-39dd-4dbb-800c-0cef422ae7c52026-01-28WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. • if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have • liver disease • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • trouble urinating due to an enlarged prostate gland • persistent or chronic cough as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin When using this product • excitability may occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if • pain or cough gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center righ...

Additional Listing Data#

Finished product
Yes
Brand name base
Leader Nighttime Cold and Flu
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE30 mg/30mL
DOXYLAMINE SUCCINATE12.5 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2
Rxcui1043400

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0184-1Leader Nighttime Cold and Flu237 mL in 1 BOTTLESOLUTION2379
70000-0184-2Leader Nighttime Cold and Flu355 mL in 1 BOTTLESOLUTION3559

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0184-1ML - Milliliter70000-0184a65b035f-31e4-42be-b431-64185428aa6b12018-12-13
70000-0184-2ML - Milliliter70000-0184addd0293-fcd3-4b0d-80b9-d814710b191012018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0184LEADER NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CARDINAL HEALTH 110, LLC. DBA LEADER]8Current NDC, Legacy NDC, 2 package rows20250412_9b1a5dbe-39dd-4dbb-800c-0cef422ae7c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSN9b1a5dbe-39dd-4dbb-800c-0cef422ae7c59
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD9b1a5dbe-39dd-4dbb-800c-0cef422ae7c59
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY9b1a5dbe-39dd-4dbb-800c-0cef422ae7c59
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY9b1a5dbe-39dd-4dbb-800c-0cef422ae7c59
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY9b1a5dbe-39dd-4dbb-800c-0cef422ae7c59

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0184-170000018401237 mL in 1 BOTTLE (70000-0184-1) 237 ml2016-11-150000-00-00NoNoCurrent
70000-0184-270000018402355 mL in 1 BOTTLE (70000-0184-2) 355 ml2016-11-150000-00-00NoNoCurrent